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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-30
Device Problems Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline had failure to open and there was catheter resistance. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right cavernous sinus segment with a max diameter of 17. 21mm and a 8. 99mm neck diameter. The landing zone was 4. 1mm and the proximal was 5. 03mm. The access vessel was the femoral artery with a diameter of 6mm. The treatment was dense mesh stent implantation for intracranial aneurysm. It was noted the patient's vessel tortuosity was moderate. Dapt (dual antiplatelet treatment) administered, aa 71%, adp 81%. Angiographic result post procedure was normal. It was reported that the aortic aneurysm of right cavernous sinus was planned to be treated with dense mesh stent implantation. At first, phenom 27 was successfully placed in the middle cerebral artery m2. Although the pipeline stent delivery had resistance in the distal end, it was smoothly pushed to the distal end and opened in the m1 segment of the middle cerebral artery. The phenom stent catheter was withdrawn. The pipeline stent was exposed but the tip could not be opened. It was deployed for a longer distance of about 13mm. After waiting, there was still no way to open it. Then was recovered with the phenom stent catheter, deployed again, and given a little tension, the middle part of the stent opened but the distal end still could not be opened. The eptfe protective sleeve was always tied to the distal end of the stent, causing the stent to be unable to be opened and had to be withdrawn as a whole. In vitro, it was found that the distal end of the stent was damaged. The pipeline was not positioned in a bend, less than 50% of the pipeline had been deployed. The pipeline was resheathed "less than or equal to 2 times. "there were no additional steps or other devices required to open the pipeline. They withdrew the pipeline and replaced with a new stent catheter phenom27, intending to be in place. A new stent was replaced, but when it was in place, it was found that the second stent catheter had great resistance when entering the hub, and it was suspected that there was a problem with the stent catheter, so it was taken out. The surgeon lost confidence and gave up pipeline treatment, and chose products from other manufacturers for treatment. The pipeline was not used for an indication that is not approved. The pipeline and any accessory devices were prepared as indicated in the ifu. The catheter was flushed as indicated in the ifu. There were no patient symptoms or complications associated with the event. Ancillary devices include a 6f long sheath, 5f navien guide catheter, phenom 27 microcatheter, transend 0. 014 guidewire, liquid embolic, and coils.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12439620
MDR Text Key270328925
Report Number2029214-2021-01128
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-30
Device Catalogue NumberPED-500-30
Device Lot NumberB160658
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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